MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA WITH BD CONNECTA AND BD Q-SYTE; INTERVASCULAR CATHETER

Catalog Number 383661

Device Problem Microbial Contamination of Device (2303)

Patient Problems Unspecified Infection (1930); Skin Inflammation (2443)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that medical intervention occurred during use with a bd nexiva with bd connecta and bd q-syte.The following information was provided by the initial reporter, "recurrent observation of inflammatory puncture sites or even infection following the use of bd nexiva catheters by the only department usually using this type of medical device in our establishment, and this despite compliance with the rules of asepsis and different fdi.Several inflammatory punctures and an infection with s.Aureus methis requiring a surgical cleaning procedure.".

Event Description

It was reported that medical intervention occurred during use with a bd nexiva with bd connecta and bd q-syte.The following information was provided by the initial reporter, "recurrent observation of inflammatory puncture sites or even infection following the use of bd nexiva catheters by the only department usually using this type of medical device in our establishment, and this despite compliance with the rules of asepsis and different fdi.Several inflammatory punctures and an infection with s.Aureus methis requiring a surgical cleaning procedure.".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 8058799.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h.10.

• Brand Name: BD NEXIVA WITH BD CONNECTA AND BD Q-SYTE
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 8906070
• MDR Text Key: 154736910
• Report Number: 9610847-2019-00523
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 383661
• Device Lot Number: 8058799
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other